Specialized Workshop M2 - Monday April 07, 2025: 7am to 5:30pm
" AGENDA -
Biomarkers Discovery, Development, Validation & Regulatory Approval
- Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders "
| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
Session 1: Current Challenges in Biomarker Assays Development/BAV: Parallelism, Free Target Measurement, GCLP vs CLIA, New Platforms
Session 2: Vaccine Biomarkers LBA: Focus on Automation, Assay Maintenance/Performance Monitoring and Complex Matrices Development/Validation
Session 3: Mass Spec Assays vs LBA for Measuring Biomarkers and EU IVDR 2017/746 Impact on Global Biomarker Strategy
Session 4: Development & Fit for Purpose Validation (FFP BAV) of CDx/IVDs: Focus on CDx for AAV- based Gene Therapies (GT)
Session 5: 2025 White Paper in Bioanalysis
| -08:00pm: |
"Recommendations on Biomarkers & Companion Diagnostics and Panel Discussions for 2025 White Paper in Bioanalysis"
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Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| 08:00pm-08:50pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Biomarkers & CDx/BAV
Regulatory Panelists:
- Mr. Abbas Bandukwala (US FDA CDER)
- Ms. Leslie Wagner (US FDA CBER)
- Dr. Joshua Xu (US FDA NCTR)
- Dr. Shirley Hopper (UK MHRA)
- Dr. Alessandra Buoninfante (EU EMA)
- Dr. Hilke Zander (Germany PEI / EU EMA)
- Dr. Joerg Engelbergs (German PEI / EU EMA)
- Dr. Chad Irwin (Health Canada)
- Dr. Julie Joseph (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
- Ms. Dulcyane Neiva Mendes (Brazil ANVISA)
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| 05:30pm-07:00pm |
Welcome Reception Mark Twain Courtyard
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